The CardioMEMS HF System, the first and only FDA-approved heart failure monitoring device, features a sensor that is implanted in the pulmonary artery (PA) during a non-surgical procedure to directly measure PA pressure. Increased PA pressures appear before weight and blood pressure changes, which are often used as indirect measures of worsening heart failure, a condition that affects more than 5.1 million people in the U.S.
The new system allows patients to transmit daily sensor readings from their homes to their healthcare providers, allowing for personalized and proactive management to reduce the likelihood of hospitalization.
“This innovative technology provides us with an efficient method of detecting changes that will allow us to intervene with heart failure patients sooner, improving their outcomes and significantly reducing their healthcare costs,” said Sandra V. Chaparro, M.D., assistant professor of medicine in the Cardiovascular Division and Director of the Heart Failure Clinic at the University of Miami Miller School of Medicine, who performed the first procedure October 20. “The CardioMEMS device also gives the patient the added benefit of knowing they can be monitored more closely, which can greatly decrease their time in the hospital.”
Heart failure occurs when the heart is unable to pump enough blood to meet the body’s demands, leaving patients with shortness of breath, trouble breathing and fatigue. According to the Centers for Disease Control and Prevention, 670,000 new cases are diagnosed each year. Patients with heart failure are frequently hospitalized, have a reduced quality of life and face a higher risk of death. The estimated cost of heart failure in the U.S. for 2012 was $31 billion, a number that is expected to more than double by 2030, according to the American Heart Association.
The CardioMEMS sensor is designed to last the lifetime of the patient and does not require batteries. Once implanted, the wireless sensor sends pressure readings to an external patient electronic system and there is no pain or sensation for the patient during the readings. The CardioMEMS HF System allows the patient to transmit critical information about their heart failure status to a clinician on a regular basis, without the need for additional clinic or hospital visits. This allows clinicians to detect worsening heart failure sooner and adjust treatment to reduce the likelihood that the patient will need to be hospitalized.
Data from a clinical trial showed that the CardioMEMS technology reduces heart failure hospital admissions by up to 37 percent. The CHAMPION trial studied the effectiveness of the CardioMEMS HF System in patients with New York Heart Association (NYHA) Functional Classification System Class III heart failure who had been hospitalized for heart failure in the previous 12 months. Results of the trial, published in The Lancet journal, demonstrated a statistically significant 28 percent reduction in the rate of heart failure hospitalizations at six months, and 37 percent reduction in heart failure hospitalizations during an average follow-up duration of 15 months.
Roughly 1.4 million patients in the U.S. have NYHA Class III heart failure, which means their cardiac disease results in marked limited physical activity. Less than ordinary activity causes fatigue, angina pain or palpitation. Historically, these patients account for nearly half of all heart failure hospitalizations, representing a significant patient population.
“Introducing the CardioMEMS System demonstrates UHealth’s commitment to providing innovative technology for our patients, allowing physicians to optimize patient care and hopefully to avoid hospitalizations,” said Robert Hendel, M.D., professor of medicine and interim Chief of the Cardiovascular Division. “The CardioMEMS system is in keeping with our academic mission to offer the latest technology and cutting edge approaches for South Florida patients.”
The CardioMEMS HF System, from global medical device manufacturer St. Jude Medical, was approved by the U.S. Food and Drug Administration for commercial use in the U.S. in May 2014.
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